Application 016367

Type: NDA
Sponsor: ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	50MG/ML	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-7922	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7922	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7922	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7922	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7922	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7922	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7923	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7923	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7923	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7923	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7923	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7923	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0990-7922	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7922	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7922	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7922	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7922	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7922	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7922	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7922	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7922	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7923	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7923	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7923	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7923	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7923	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7923	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7923	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7923	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7923	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
51662-1211	5% DEXTROSE	5% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1211	5% DEXTROSE	5% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1211	5% DEXTROSE	5% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1214	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1214	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1214	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1306	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1306	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1306	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1413	5% DEXTROSE	5% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1413	5% DEXTROSE	5% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1493	DEXTROSE MONOHYDRATE	DEXTROSE MONOHYDRATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1493	DEXTROSE MONOHYDRATE	DEXTROSE MONOHYDRATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82526	SUPPL	2025-06-10
82518	SUPPL	2025-06-10
12991	SUPPL	2006-10-31
10888	SUPPL	2006-10-27
10887	SUPPL	2005-09-07
442	SUPPL	2005-09-07

Application 016367

Related Records#

Application Products#

NDC Listings For This Application#

Documents#